State
73,100 recalls have nationwide distribution and so reach Virginia. 9,492 additional recalls listed Virginia specifically in their distribution scope.
Of the 9,492 recalls naming Virginia we have scored against our rubric, 1,286 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,302 (24%) are Severe.
Which agencies issued them
These figures cover only the 9,492 recalls whose distribution notice names Virginia specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.
Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.
LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.
Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.
Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.
Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.
Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Iovate Health Sciences is recalling Alpha Test 120-count capsules containing cathine, an unapproved ingredient not permitted in dietary supplements. Affected products were distributed across the United States and internationally.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.